On March 31, 2022 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, reported financial results for 2021 and recent business progress (Press release, TransCode Therapeutics, MAR 31, 2022, View Source [SID1234611344]).

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"2021 was a foundational year for TransCode, highlighted by our successful IPO on Nasdaq in July," said Michael Dudley, co-founder, president and CEO of TransCode. "With resources from the IPO, as well an important Small Business Innovation Research (SBIR) grant, we drove significant progress across the organization, including key additions to our team that bring valuable expertise, and continued advancement of our lead candidate and our preclinical development programs. We are now building on this foundation as we move toward clinical development which we expect will demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology."

TransCode Therapeutics co-founder and Chief Technology Officer, Dr. Zdravka Medarova, added, "We are on track to submit an exploratory Investigational New Drug Application (eIND) this year to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Key 2021 Highlights

·Completed an over-subscribed initial public offering on Nasdaq in July, raising gross proceeds of $28.8 million; the Company’s outstanding convertible promissory notes were converted into common stock upon completion of the IPO.

·Expanded the leadership team with the appointment of TransCode’s scientific co-founder, Zdravka Medarova, Ph.D., as Chief Technology Officer effective October 1. Dr. Medarova is a leader in the field of non-coding RNA delivery to cancer and has authored multiple high-impact publications on the topic of RNA delivery, nanotechnology, and the biology of cancer metastasis. Leadership team further strengthened in 2021 with additional key appointments, including:

Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D, as Principal Scientist; and
Dejan Juric, M.D., appointed to the Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and a breast cancer specialist, serves as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.

·Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million. The award is a fast track award based on milestones achievement, to support the clinical evaluation of TTX-MC138, including translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery of TTX-MC138.

Expected Upcoming Milestones

TransCode’s goals to continue to advance its portfolio include:

·TTX-MC138

Submission to FDA of an eIND application for First-in-Human (FIH) clinical trial.
Initiation of a FIH Phase 0 clinical study evaluating delivery of TTX-MC138 to metastatic lesions in 10 Stage IV patients with solid tumors
Concurrent completion of IND-enabling studies to support filing of an IND application for a Phase I clinical trial of TTX-MC138.

·Publication of preclinical results supporting the lead therapeutic candidate TTX-MC138 in pancreatic cancer and glioblastoma multiforme.

·Continuation of preclinical studies for therapeutic candidates TTX-RIGA, TTX-siPDL1, and TTX-siLin28b.

2021 Financial Highlights (in millions)

•Cash: $ 20.8
•R&D Expenses: $ 2.8
•G&A Expenses: $ 3.4
•Operating Loss: $ 6.8

Financial Guidance

TransCode expects that its cash of $20.8 million as of December 31, 2021, together with additional funding expected from an April 2021 SBIR award, are sufficient to fund planned operations into the first quarter 2023 but not for a full 12 months from the date of our financial statements.

Conference Call

The Company will host an investor conference call at 4:30 p.m. ET on April 7, 2022. A question-and-answer session will follow management’s presentation.

If you are unable to participate during the live call, the call will be recorded and later made available on the Company’s website.

On March 31, 2022 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported the pricing of its previously announced underwritten public offering of 4,629,630 shares of its common stock and accompanying warrants to purchase up to 4,629,630 shares of common stock at a combined public offering price of $5.40 per share and accompanying warrant (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611335]). The warrants to purchase shares of common stock have an exercise price of $5.40 per share, are immediately exercisable and will expire five years from the date of issuance. All of the securities in the offering will be sold by SELLAS, with gross proceeds to SELLAS expected to be $25.0 million before deducting underwriting discounts and commissions and offering expenses. The offering is expected to close on April 5, 2022, subject to the satisfaction of customary closing conditions.

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SVB Leerink and Cantor are acting as joint book-running managers for the offering.

The public offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 31, 2022 Carina Biotech reported that we have submitted a pre-IND (Investigational New Drug) application to the US FDA (Food & Drug Administration) for our CAR-T therapy that targets a cancer stem cell antigen known as LGR5 (Press release, Carina Biotech, MAR 31, 2022, View Source [SID1234611333]).

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This represents a major step towards taking our CAR-T cell (CNA3103) into a Phase I/IIa clinical trial in patients with advanced colorectal (bowel) cancer later this year.

HIGHLIGHTS

A pre-IND package submission comes before a pre-IND meeting with the FDA, which will occur on 26 April
The next step will be the full IND application anticipated at the end of September 2022
Carina’s LGR5 CAR-T cells are targeted at LGR5, a cancer stem cell marker that is highly expressed on colorectal cancer (and other cancers)
Colorectal cancer is the deadliest cancer for Australians aged 25-34 and Australia’s second deadliest cancer overall
More than $US1 billion was earned by CAR-T therapy products in 2020*; and revenue of $US20.3 billion is forecast for 2028**
Carina Biotech CEO, Dr Deborah Rathjen said:

"Submitting our pre-IND package to the FDA is a milestone achievement for Carina as we transition from a discovery-stage pre-clinical company to a clinical-stage company, addressing unmet clinical needs in the treatment of solid cancers using our proprietary CAR-T technology to generate effective therapies that harness the power of the immune system."

Colorectal cancer is the third most commonly diagnosed cancer in Australia and in the United States, and the second leading cause of cancer deaths in Australia.

Metastatic colorectal cancer represents a significant unmet clinical need and has a large market potential. The therapeutics market is estimated at US$10.4 billion pa, growing at 4.6% pa.***

New CAR-T product approvals are anticipated to expand to an addressable patient population of 2 million within the next 10 years****, with solid tumours anticipated to account for more than 50% of CAR-T revenues by 2030*****.

About Carina’s LGR5 CAR-T cell
LGR5 is a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5+ expression has been correlated with a particularly poor prognosis.

Cancer stem cells are a small sub-population of cells within a tumour with the ability to self-renew, differentiate into the many cell types of a tumour, initiate new tumours, and resist chemotherapy and radiotherapy (leading to relapses).

By targeting cancer stem cells, it is hoped that this therapy will reduce the tumour’s ability to generate new cancer cells, resulting in durable tumour suppression and preventing the relapses that are very common in patients with colorectal cancer.

Carina’s pre-clinical studies of the LGR5-targeted CAR-T cell have shown highly promising results with complete tumour regression and no tumour recurrence. They have also demonstrated impressive tumour access and prolonged CAR-T cell survival.

REFERENCES
*Yescarta and Kymriah market size estimates calculated from various publicly available sources. Estimates vary and different analyses may give different results. Estimated cost of goods US$58,200 (range $40,000-$106,000, 2018) with pricing outcomes/value based.
** Grandview Research, ‘T-cell therapy market size, share and trends analysis’, Feb 2021.
*** Calculated as the average of estimates published by Reportlinker, BCC Research and Nature Reviews Drug Discovery. Estimates vary and other analyses may give different results. Prevalence data is for US cases only.
**** Grandview Research, ‘T-cell therapy market size, share and trends analysis’, Feb 2021.
***** Polaris Market Research, ‘CAR-T cell therapy market share, size trends, industry analysis report’, June 2021.

On March 31, 2022 Canthera Discovery reported that its predecessor, Cancer Therapeutics CRC, received the Cooperative Research Australia (CRA) Excellence in Innovation Award for Research Commercialisation at an award ceremony at Parliament House in Canberra on Thursday night (Press release, Canthera Discovery, MAR 31, 2022, View Source [SID1234611332]).

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Cancer Therapeutics CRC, ran for 13 years (2007-2020) and was recognised for landing deals in ground-breaking cancer therapies with pharma giants for a headline value of close to A$1.4bn. It has 7 licensed programs in active development, including two currently in clinical trials.

"The CRC Program funded Cancer Therapeutics CRC with $71m over 13 years. In potentially returning some ten times that investment and counting in licensing deals, Cancer Therapeutics CRC and Canthera Discovery have been a shining example of the strength of the CRC Program in bridging the gap between domestic world class research and innovation, and global commercialisation," CRA CEO Jane O’Dwyer said.

"Cooperative Research Australia is delighted to present Canthera Discovery and Cancer Therapeutics CRC with the Award for Research Commercialisation," she said.

Brendon Monahan, Chief Scientific Officer, Canthera Discovery
Upon receiving the award, Brendon Monahan, Canthera Discovery Chief Scientific Officer commented, "Drug discovery requires a multi-disciplinary approach and collaboration is at the centre of everything we do. We would like to thank and acknowledge our Research Partners: WEHI, CSIRO, Monash University, Griffith University, Children’s Cancer Institute, and the Peter MacCallum Cancer Centre. Our CRC commercialisation partners SYNthesis Research and Oncology One. And all of our CRC participants."

"It is no secret that what has driven the success of Cancer Therapeutics CRC and now Canthera, is its people. The KAT6 project alone, which entered clinical trials in 2020, involved over 100 people, across 16 organisations, 10 research laboratories, and 11 different general fields combining science, business, and data management. We thank everyone, past and present, who have contributed expertise, creativity, and passion to our organisation and projects."

On March 31, 2022 Insud Pharma reported that it has entered into an agreement with Fresenius Kabi (Press release, mAbxience, MAR 31, 2022, View Source [SID1234611328]). Under the terms of the agreement Fresenius Kabi will acquire 55% of mAbxience, the global fully-fledged biotech company of the Spanish group.

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Founded in 2010, mAbxience has over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. The company operates three state-of-the-art and R&D manufacturing facilities, located in Spain and Argentina, and has been developing a range of biopharmaceutical products focused on multiple therapeutic areas. mAbxience also offers contract development and manufacturing (CDMO) services to customers.

The company has successfully established alliances with key partners which have enabled multiple biosimilars to be launched across international markets allowing patients access to high quality biopharmaceutical products on a global basis.

As a result of this agreement, mAbxience will continue its ambitious growth plans and will keep its well-defined corporate identity, and team of around 600 professionals, ensuring continuity of its current business strategy. The boards of directors of both companies have unanimously approved the transaction, which is expected to close by midyear 2022, subject to regulatory and other conditions customary for a transaction of this type.

With this alliance, Insud Pharma plans to accelerate its biotech unit, bringing new and exciting opportunities to mAbxience customers and increasing its research activities – at the beginning of May, it is expected to open a new R&D facility in Spain-.

Furthermore, this transaction will be meaningful for the Spanish group Insud Pharma, which will continue to grow and invest worldwide, whilst entering into new activities.

"We’re delighted to announce our combination with Fresenius Kabi for the future development of mAbxience. This collaboration recognizes mAbxience’ s capabilities in biopharmaceuticals and our strong team of dedicated employees. This transaction is a tremendous opportunity to add further value to the industry, to make mAbxience bigger and stronger and to collaborate and work together with a company such as Fresenius Kabi", stated Lucas Sigman, CEO at Insud Pharma.

"mAbxience is the perfect example of how innovation, cutting-edge R&D and manufacturing platform technology is used to deliver high quality medicines to patients, provide cost-effective alternatives to healthcare systems and guarantee its sustainability. Today’s announcement is testament to the hard work of our people that have grown mAbxience from its inception to the leading business it is today", stated Sigman.

He continued "Furthermore, this is also great news for Insud Pharma. This transaction will give our company the chance to continue investing more and to open the door to faster expansion into new areas and opportunities. As joint partners with Fresenius Kabi, we fully expect to further accelerate our mission to deliver affordable medicines to patients worldwide", stated Sigman.

Emmanuelle Lepine, mAbxience CEO, said "We believe this new strategic partnership with Fresenius Kabi represents the best possible next step in line with mAbxience´s strategic growth plan. This partnership will allow the further progression of our development pipeline and will enable the acceleration of our capacity expansion, both of which will benefit patients, customers, and health systems. This new stage in the evolution of our company will bolster opportunities to grow our biopharmaceutical platform in key areas of high technological development and manufacturing, as well as accelerate access in strategic markets, adding a key collaboration to our already strong global partnership base".

She continued "Driven by a shared value in people and purpose, this partnership with Fresenius Kabi will enable mAbxience to advance towards its vision of bringing biopharma solutions that are Affordable, Accessible and Across the globe. We are convinced that this partnership will enhance our commitment to the long-term sustainable growth potential for the business and will be highly beneficial to the growth and development of the whole team".

Goldman Sachs acted as exclusive financial advisor to Insud Pharma, while Baker McKenzie acted as legal advisor.